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WithdrawnNCT04274166Updated May 28, 2021

Secukinumab for the Inflammatory Phase of Pyoderma Gangrenosum

A Phase 2 interventional study of secukinumab 150 mg (2 injections per dose in Pyoderma Gangrenosum, sponsored by Wake Forest University Health Sciences. Withdrawn. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-05-28.

Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Contracting never completed, closed the IRB
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this research study is to find out what effects (good and bad) secukinumab has on the subject and their pyoderma gangrenosum.

Secukinumab is a type of medicine called human monoclonal antibodies. Monoclonal antibodies are proteins that recognize and attach to other specific proteins (in this case, immune system hormones called "cytokines") that your body produces. The cytokine (a "messenger" protein in the body) that secukinumab binds to and reduces the activity of is a naturally occurring cytokine called interleukin-17A (IL-17A). IL-17A is believed to be partly responsible for inflammation (pain, swelling, redness), and researchers believe that IL-17A may cause symptoms PG.

Read the detailed description

This is a prospective, single center, Phase IIa study of secukinumab in the treatment of subjects diagnosed with PG. Subjects will be evaluated at Screening, Baseline (week 0), Week 1, Week 2, Week 3, Week 4, and then every 4 weeks for 24 weeks. The total duration of treatment is up to 20 weeks. Subjects may be treated for shorter durations if the lesions clear prior to week 20. Subjects will have a follow-up visit at 24 weeks, or 4 weeks after the last dose of study drug. Subjects will also have standard of care wound dressings done at each visit. Subjects will be given 300 mg of secukinumab SQ at week 0, 1, 2, 3, and 4, followed by injections every 4 weeks, for up to 20 weeks. Subjects may receive a dose increase at week 16 (if there is not at least a 25% reduction in target lesion size) to 300 mg every 2 weeks.

  • Complete Blood Count (CBC), Comprehensive Metabolic panel (CMP), C- reactive protein (CRP), Erythrocyte sedimentation rate (ESR), Hepatitis panel, HIV test, Pregnancy test, and QuantiFERON gold TB test will be performed at screening. (Appendix 6)
  • CBC, CMP, CRP, ESR will be performed at week 8 and week 20.
  • Pain rating by Likert scale (A 10-point scale to rate the level of pain - Appendix 2), an Investigator Global Assessment (IGA) (Appendix 3), Subject Global Assessment (SGA) (Appendix 3), and Ulcer Lesion Assessment (Appendix 5) will be done at Screening, Baseline, and at Weeks 2, 4, 8, 12, 16, 20, and 24.
  • Lesion photography will be done at Screening and all visits.
  • Infection and adverse event assessments and concomitant medication assessments will be performed at each visit.
  • Quality of life will be measured with the Dermatology Life Quality Index (DLQI) at Baseline and Week 20 (Appendix 4).
02

Conditions studied

  • Pyoderma Gangrenosum
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Must give written informed consent. 2. Has a diagnosis of pyoderma gangrenosum, as determined by the investigator based on the following diagnostic criteria4:

a. Diagnosis requires both major criteria and at least two minor criteria i. Major criteria

  1. Rapid progression of a painful, necrolytic cutaneous ulcer with an irregular, violaceous, and undermined border
  2. Other causes of cutaneous ulceration have been excluded ii. Minor criteria
  1. History suggestive of pathergy or clinical finding of cribriform scarring 2. Systemic diseases associated with PG 3. Histopathologic findings (sterile dermal neutrophilia, ± mixed inflammation, ± lymphocytic vasculitis) 4. Treatment response (rapid response to systemic steroid treatment)
  1. PG global assessment of moderate to severe, with at least one ulcer measuring at least 3 cm in diameter.
  1. 18 years of age or greater. 5. Must require systemic therapy for their pyoderma gangrenosum, as determined by the investigator prior to Baseline. Currently prescribed low-dose corticosteroids (≤ 10 mg/day), and other medications within one week prior to investigational drug administration, may be continued with no change in dose or frequency during the study.

Exclusion criteria

Exclusion Criteria:

  1. Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
  2. Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed).
  3. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
  4. Treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration.
  5. Treatment with high dose (>10 mg/day) systemic steroids (prednisone) within one week prior to investigational drug administration. Treatment with cyclosporine, thalidomide, methotrexate, mycophenolate mofetil, azathioprine, or other systemic immunosuppressant agents within the 14 days prior to investigational drug administration (requirement of a 2-week washout).
  6. Known HIV+, known viral hepatitis infection, known tuberculosis infection.
  7. Any subject with a current or history of a malignancy in the last five years (excluding treated basal cell carcinoma).
  8. Clinically significant abnormal laboratory measures at screening.
  9. Known Irritable Bowel Disease-associated PG
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Experimental

    2 s.c. secukinumab 150 mg injections

    Drug: secukinumab 150 mg (2 injections per dose

Interventions

  • Drugsecukinumab 150 mg (2 injections per dose

    secukinumab 150 mg (2 injections per dose

    Also known as: secukinumab

05

What researchers measure

Primary outcomes

  1. Efficacy - Investigator Global Assessment (IGA)

    Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

    Time frame: Screening visit

  2. Efficacy - Investigator Global Assessment (IGA)

    Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

    Time frame: Change from Screening visit to Baseline visit.

  3. Efficacy - Investigator Global Assessment (IGA)

    Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

    Time frame: Change from Baseline visit to Week 2.

  4. Efficacy - Investigator Global Assessment (IGA)

    Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

    Time frame: Change from week 2 to week 4.

  5. Efficacy - Investigator Global Assessment (IGA)

    Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

    Time frame: Change from Week 4 to week 8.

  6. Efficacy - Investigator Global Assessment (IGA)

    Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

    Time frame: Change from Week 8 to week 12.

  7. Efficacy - Investigator Global Assessment (IGA)

    Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

    Time frame: Change from Week 12 to week 16.

  8. Efficacy - Investigator Global Assessment (IGA)

    Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

    Time frame: Change from Week 16 to week 20.

  9. Efficacy - Investigator Global Assessment (IGA)

    Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

    Time frame: Change from Week 20 to week 24.

  10. Efficacy - Subject Global Assessment (SGA)

    Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

    Time frame: Baseline.

  11. Efficacy - Subject Global Assessment (SGA)

    Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

    Time frame: Change from Baseline to week 2.

  12. Efficacy - Subject Global Assessment (SGA)

    Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

    Time frame: Change from Week 2 to Week 4.

  13. Efficacy - Subject Global Assessment (SGA)

    Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

    Time frame: Change from Week 4 to Week 8. .

  14. Efficacy - Subject Global Assessment (SGA)

    Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

    Time frame: Change from Week 8 to Week 12.

  15. Efficacy - Subject Global Assessment (SGA)

    Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

    Time frame: Change from Week 12 to Week 16.

  16. Efficacy - Subject Global Assessment (SGA)

    Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

    Time frame: Change from Week 16 to Week 20.

  17. Efficacy - Subject Global Assessment (SGA)

    Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"

    Time frame: Change from Week 20 to Week 24.

  18. Efficacy - Ulcer Lesion Assessment PG Target Lesion

    Number of subjects achieving 50% improvement in PG lesion size

    Time frame: Change from Screening visit, Baseline, and at Weeks 2, 4, 8, 12, 16, 20, and 24.

  19. Efficacy - Ulcer Lesion Assessment PG Target Lesion

    Number of subjects achieving resolution of inflammation with an erythema score of 0 and a border elevation of 0 on five point scales of none to very severe

    Time frame: Change from Screening visit, Baseline, and at Weeks 2, 4, 8, 12, 16, 20, and 24.

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04274166
Lead sponsor
Wake Forest University Health Sciences
Collaborators
Novartis
Responsible party
Sponsor
First posted
Feb 18, 2020
Start date
May 2021 (estimated)
Primary completion
Dec 2021 (estimated)
Completion
Apr 2022 (estimated)
Last update
May 28, 2021

Study contacts

William W Huang, MD. MPH
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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